CurrentEmblemHealthPolicy Evolent Clinical Guideline 3140

Evolent Clinical Guideline 3140 for Cablivi TM (caplacizumab-yhdp)

Defines accepted indications, clinical criteria, exclusions, contraindications, warnings, and billing code(s) for Cablivi (caplacizumab-yhdp) use in aTTP across EmblemHealth/Evolent lines of business. Describes continuation rules, evidence sources, and administrative responsibilities for medication requests.

Policy Summary

PayerEmblemHealth

PolicyEvolent Clinical Guideline 3140 for Cablivi TM (caplacizumab-yhdp)

Policy CodePolicy Evolent Clinical Guideline 3140

Change TypeTemplate conversion; verbiage update

Effective DateJul 1, 2025

Next Review Date

Key ActionEvolent is responsible for processing medication requests; ensure requests are supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature and document concurrent plasma exchange and immunosuppressive therapy when requesting Cablivi.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template; replaces UM ONC_1353 Cablivi (caplacizumab-yhdp).

Updated NCH verbiage to Evolent (July 2024).

1Covered Indications (aTTP)

1HCPCS drug code listed

11Single dose limit (mg)

30dMax duration after plasma exchange

Coverage Summary

Scope: Defines accepted indications, clinical criteria, exclusions, contraindications, warnings, and billing code(s) for Cablivi (caplacizumab-yhdp) use in acquired thrombotic thrombocytopenic purpura (aTTP) across EmblemHealth/Evolent lines of business. Subject: Cablivi (caplacizumab-yhdp) coverage for acquired thrombotic thrombocytopenic purpura (aTTP). Policy number: Evolent Clinical Guideline 3140. Status: CURRENT. Effective date: 2025-07-01. Coverage stance: covered_with_criteria.

Key thresholds and billing

Single dose limit11 mg

Maximum duration beyond last plasma exchange30 days (may extend an additional 28 days if ADAMTS13 activity remains suppressed for a total of 2 treatment courses)

Continuation lapse allowanceMedication must have been used within the last year without a lapse of more than 30 days of active authorization

Covered Indication (aTTP)Acquired thrombotic thrombocytopenic purpura (aTTP) when used with plasma exchange and immunosuppressive therapy

HCPCS drug code listedC9047 (Injection, caplacizumab-yhdp, 1 mg)

Medical-Necessity Criteria

Initial therapy - Indication and required concomitant therapy

Covered when ALL of the following are met:

ALL of the following

Member has acquired thrombotic thrombocytopenic purpura (aTTP).
Cablivi (caplacizumab-yhdp) is being used in combination with plasma exchange and immunosuppressive therapy (e.g., systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, or vincristine).
Immunosuppressive therapy may be tapered or discontinued at physician/provider discretion.
Use is supported by FDA labeling, CMS-approved compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

Continuation therapy (exceptions to non-approvable medications)

Coding

Drug billing codeHCPCSCovered

C9047

Injection, caplacizumab-yhdp, 1 mg

Provider Actions

Prior Authorization

Prior authorization required

Evolent requires prior authorization for Cablivi (caplacizumab-yhdp). Medication requests must be supported by FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Affected code: C9047 (Injection, caplacizumab‑yhdp, 1 mg)
Required evidence sources: FDA product labeling; CMS‑approved compendia; NCCN or ASCO clinical guidelines; acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Documentation of concomitant therapy

Document that Cablivi is being administered in combination with plasma exchange and immunosuppressive therapy. When immunosuppressive therapy is tapered or discontinued, include the clinical rationale in the request.

Background and Evidence

Indication summary: Cablivi (caplacizumab-yhdp) is indicated for acquired thrombotic thrombocytopenic purpura (aTTP) and must be used in combination with plasma exchange and immunosuppressive therapy (examples: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, or vincristine); immunosuppressive therapy may be tapered or discontinued at the treating provider's discretion. Payer expectation: medication requests must be supported by recognized evidence sources consistent with CMS (e.g., FDA labeling, CMS‑approved compendia, NCCN, ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15).

Label	Value
Key randomized trial	HERCULES trial (Scully M et al., N Engl J Med. 2019 Jan 24;380(4):335-346).
Prescribing information	Cablivi prescribing information, Genzyme Corporation. 2024.

Definitions

Continuation requestA request to continue a medication previously authorized; continuation may be exempt when no disease progression, prior use within last year without >30 day lapse, and no additional medications are added.

Clinically meaningful outcomesPer ASCO guidance, examples include hazard ratio < 0.80 and recommended survival benefit for OS/PFS of at least 3 months.

Revision History

July 2025converted/replaced

Converted to new Evolent guideline template; replaces UM ONC_1353 Cablivi (caplacizumab-yhdp). Detail: Updated references. Marked non-material per brief.

July 2024verbiage update

Updated NCH verbiage to Evolent (July 2024). Marked non-material per brief.

Policy Summary

PayerEmblemHealth

PolicyEvolent Clinical Guideline 3140 for Cablivi TM (caplacizumab-yhdp)

Policy CodePolicy Evolent Clinical Guideline 3140

Change TypeTemplate conversion; verbiage update

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Continuation requests for a medication that would otherwise be not-approvable are covered when ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication.
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
Additional medication(s) are not being added to the continuation request.

Document concurrent plasma exchange
Document concurrent immunosuppressive therapy (examples: systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, vincristine)
If tapering or discontinuing immunosuppression, provide rationale

Denial Risk

Denial risk for investigational/off-label insufficient evidence

Requests for investigational or off‑label use lacking adequate supporting evidence may be excluded and denied.

Evidence limited to case reports or abstracts without full peer‑reviewed articles
Published evidence that does not adequately represent the patient population or concomitant therapy regimens
Reported outcomes that are not clinically meaningful (per ASCO examples, e.g., hazard ratio ≥ 0.80 or survival benefit < 3 months)

Billing Rule

Dose and duration limits

Claims exceeding the policy dose or duration thresholds are subject to denial.

Single dose limit: 11 mg
Maximum duration: 30 days beyond the last plasma exchange
Allowed extension: additional 28 days (for a total of 2 treatment courses) only if ADAMTS13 activity remains suppressed
Claims exceeding these dose or duration limits may be denied